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Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

NCT03795298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2025-09-18

Study results available
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Summary

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

Conditions

Interventions

DEVICE

WATCHMAN FLX Implant

Left atrial appendage closure with the WATCHMAN FLX device

DRUG

Market-approved OAC

Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Oussama Wazni, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2024-07-24
Completion
2024-07-24
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795298 on ClinicalTrials.gov